Closure devices and methods

ABSTRACT

A method for closing a puncture in a vessel wall of a blood vessel that includes advancing a guide member into proximity with a puncture in a vessel wall, positioning a distal end of an angle adjustment member distal to openings of the guide member, deploying the needle guides from the guide member through the openings, advancing the deflected needle guides and the suture securing devices through the vessel wall, retracting the needle guides to release the suture securing devices distally of the vessel wall, and establishing tension in the sutures to move the suture securing devices toward each other to thereby close the puncture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/112,618, titled CLOSURE DEVICES AND METHODS, filed May 20, 2011,which is a continuation-in-part of U.S. patent application Ser. No.12/684,470, titled CLOSURE DEVICES, SYSTEMS, AND METHODS, filed Jan. 8,2010, which claims the benefit of U.S. Provisional Application No.61/143,751, titled VESSEL CLOSURE DEVICES AND METHODS, filed Jan. 9,2009, which are incorporated herein by reference in their entireties.

BACKGROUND

1. Technical Field

The present disclosure relates generally to medical devices and theirmethods of use. In particular, the present disclosure relates to vesselclosure devices and corresponding methods of use.

2. The Technology

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and tissue into the vascular system. A guidewire may beadvanced through the needle and into the patient's blood vessel accessedby the needle. The needle is then removed, enabling an introducer sheathto be advanced over the guidewire into the vessel, e.g., in conjunctionwith or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of theintroducer sheath and over the guidewire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath areremoved, leaving a puncture site in the vessel wall. Traditionally,external pressure would be applied to the puncture site until clottingand wound sealing occur; however, the patient must remain bedridden fora substantial period after clotting to ensure closure of the wound. Thisprocedure may also be time consuming and expensive, requiring as much asan hour of a physician's or nurse's time. It is also uncomfortable forthe patient and requires that the patient remain immobilized in theoperating room, catheter lab, or holding area. In addition, a risk ofhematoma exists from bleeding before hemostasis occurs. Although someclosure systems may be available, they provide limited control andflexibility to the operator, which may lead to improper or undesirableclosure of the puncture site.

BRIEF SUMMARY

The present invention provides a vessel closure device that is bothmanageable and versatile. A vessel closure device is provided that mayinclude a guide member and one or more needle guides disposed at leastpartially within the guide member. The needle guides may be configuredto move between a first position wherein the needle guides aresubstantially straightened at least partially within the guide memberand a second position wherein the needle guides at least partiallyextend radially and distally away from the guide member. The vesselclosure device may further include an angle adjustment member movablyattached to the guide member. The angle adjustment member may beconfigured to move between a first position and a second positionwherein the angle adjustment member can selectively deflect the needleguides radially toward the guide member when the needle guides are inthe second position.

A vessel closure device is provided that may include a guide member andone or more needle guides moveably connected to the guide member. Theneedle guides may be configured to move between a first position whereinthe needle guides are adjacent to the guide member and a second positionwherein the needle guides at least partially extend distally away andradially outward from the guide member at a first angle. The vesselclosure device may further include an angle adjustment member slidablyattached to the guide member. The angle adjustment member may beconfigured to selectively reduce the first angle of the needle guides inthe second position by selectively urging the needle guides toward theguide member.

A suture securing device is provided that may include an elongated bodyhaving a proximal end, a distal end, and an inner cavity. The elongatedbody may further include a first opening in the proximal end that is incommunication with the inner cavity. The elongated body may furtherinclude a cutout extending distally from the first opening. The cutoutmay include tissue-engaging elements. The elongated body may be attachedto a suture. The elongated body may be moveable between a first positionwherein the elongated body is substantially parallel with a longitudinalaxis of the suture and a second position wherein the elongated body issubstantially non-parallel with the longitudinal axis of the suture andat least a portion of the suture is received within the cutout such thatthe elongated body can resist proximal movement against a distal surfaceof a vessel wall.

A suture securing device is provided that may include a body having aproximal end, a distal end, and an inner cavity. The body may furtherinclude a first opening in the proximal end and a second opening in thedistal end, both in communication with the inner cavity. The body mayfurther include elongated slots extending distally from the proximalend. The slots may define projections therebetween that have a fixed endconnected to the body and a free end. The body may be attached to asuture extending through the inner cavity. The projections may bemoveable between a first configuration wherein the projections aresubstantially parallel with a longitudinal axis of the body and a secondconfiguration wherein the projections extend radially outwardly from thebody such that the body can resist proximal movement against a distalsurface of a vessel wall.

A vessel closure system is provided that may include a plurality ofneedle carriers having a distal end and a proximal end. The system mayalso include a plurality of detachable needles configured to resistproximal movement when deployed through a vessel wall. At least one ofthe detachable needles may be detachably coupled to the distal end ofone of the needle carriers. The system may also include at least onesuture secured to each of the detachable needles. A guide member canhave a plurality of first lumens extending distally from a proximal endtoward a distal end of the guide member. Each of the first lumens can besized to receive one of the needle carriers and one of the detachableneedles coupled to the needle carrier. The first lumens can also beconfigured to direct the needle carrier and the detachable needleradially outward and distally away from the guide member. The system mayalso include an outer housing that has a second lumen defined between adistal end and a proximal end of the outer housing. The second lumen canbe configured to receive at least a portion of the guide member. Thedistal end of the outer housing may also include a tapered tip portion.The tapered tip portion can be configured to move between a firstconfiguration and a second configuration. An anchor member can also beconfigured to be at least partially disposed within the second lumen.The anchor member can comprise an anchor portion and an elongateportion. The anchor member can be disposed in the inner lumen in aninitial configuration and move to an expanded configuration oncepositioned distally from the distal end of the outer housing. Finally,the system may include an expandable plug positioned between the guidemember and the anchor member.

A method of closing a puncture in a vessel wall is provided that mayinclude advancing a guide member into proximity with a puncture in avessel wall, the guide member having openings near a distal end aplurality of needle guides disposed within. A distal end of an angleadjustment member, slidably coupled to the guide member, may then bepositioned distal to the openings of the guide member. The needle guidesand sutures and suture securing devices disposed within the needleguides may then be deployed distally and radially away from the guidemember. The angle adjustment member may then deflect the needle guidestoward a longitudinal axis of the guide member. The deflected needleguides and suture securing devices may then be advanced through thevessel wall. Thereafter, the needle guides may be retracted into theguide member to release the suture securing devices. Tension may then beestablished in the sutures to move the suture securing devices towardeach other to thereby close the puncture.

These and other advantages and features of the present disclosure willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the disclosure as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify at least some of the advantages and features of thepresent disclosure, a more particular description of the disclosure willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the disclosure and aretherefore not to be considered limiting of its scope. The disclosurewill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1A illustrates a side view of a closure device according to oneexample;

FIG. 1B illustrates an exploded view of the closure device of FIG. 1A;

FIG. 1C illustrates a cross-sectional view of the guide member andassociated first plunger of FIG. 1B taken along section 1C-1C of FIG.1B;

FIG. 1D illustrates a cross-sectional view of the closure device shownin FIG. 1A taken along section 1D-1D of FIG. 1A;

FIG. 2A illustrates a closure device in a pre-deployed state accordingto one example;

FIG. 2B illustrates the closure device of FIG. 2A in an intermediatestate according to one example;

FIG. 2C illustrates the closure device of FIGS. 2A-2B in a deployedstate;

FIG. 3A illustrates steps for closing a puncture in a vessel wall inwhich a closure device is in a pre-deployed state and in proximity to anarteriotomy according to one example;

FIG. 3B illustrates steps for closing a puncture in a vessel wall inwhich the closure device of FIG. 3A is located relative to a vesselwall;

FIG. 3C illustrates steps for closing a puncture in a vessel wall inwhich detachable needles are deployed through the vessel wall;

FIG. 3D illustrates a more detailed view of engagement between adetachable needle and the vessel wall of FIG. 3A;

FIG. 3E illustrates steps for closing a puncture in a vessel wall inwhich the sutures and needles are secured in place to close the puncturein the vessel wall;

FIG. 4 illustrates a detachable needle according to one example;

FIG. 5A illustrates a distal portion of a closure device according toone example;

FIG. 5B illustrates the closure device shown in FIG. 5A in a deployedstate;

FIG. 6A illustrates a cross-sectional view of the closure device shownin FIG. 5A located relative to a vessel wall in a pre-deployed state;

FIG. 6B illustrates a cross-sectional view of the closure device shownin FIG. 5A located relative to a vessel wall in a semi-deployed state;

FIG. 7A illustrates a side view of a closure device according to oneexample;

FIG. 7B illustrates a perspective view of needle guides removed from theclosure device shown in FIG. 7A;

FIG. 8A illustrates a cross-section view of the closure device takenalong section 6-6 of FIG. 7A with the needle guides in a pre-deployedstate and an angle adjustment member in a retracted position;

FIG. 8B illustrates the closure device shown in FIG. 8A with the needleguides deployed from the closure device and the angle adjustment memberin the retracted position;

FIG. 8C illustrates the closure device shown in FIG. 8A with the needleguides deployed from the closure device and the angle adjustment memberin an extended position;

FIG. 8D illustrates the closure device shown in FIG. 8A with the needleguides deployed from the vessel closure device and the angle adjustmentmember in an intermediate position;

FIG. 9A shows a perspective view of a suture securing device accordingto one example;

FIG. 9B shows the suture securing device shown in FIG. 9A deployedthrough a vessel wall in a low-profile configuration within a needleguide;

FIG. 9C shows the suture securing device shown in FIG. 9B released fromthe needle guide in an expanded configuration.

FIG. 10A shows a perspective view of a suture securing device accordingto one example;

FIG. 10B shows the suture securing device shown in FIG. 10A deployedthrough a vessel wall in a collapsed configuration within a needleguide; and

FIG. 10C shows the suture securing device shown in FIG. 10B releasedfrom the needle guide in an expanded configuration.

It should be noted that the figures are not drawn to scale and thatelements of similar structures or functions are generally represented bylike reference numerals for illustrative purposes throughout thefigures. It also should be noted that the figures are only intended tofacilitate the description of example configurations of the presentdisclosure.

DETAILED DESCRIPTION

The present disclosure relates to devices and methods for closing anopening in a body lumen. In one example embodiment, a closure device ofthe present disclosure may allow an operator to quickly and efficientlyclose a body lumen opening or puncture in a vessel wall whilesimultaneously providing the operator with a greater measure of controland flexibility in positioning and anchoring the closure device thanpreviously available. For example, the closure device may allow anoperator to achieve a more intimate securement of a suture securingdevice in the tissue surrounding a body lumen opening. In a furtherembodiment, the closure device may be compatible with a wider range ofbody lumen wall thicknesses, thereby taking into account the possibilityof calcifications or scar tissue in the lumen wall. In yet a furtherembodiment, the closure device may be compatible with varying sizes ofbody lumen openings.

FIG. 1A illustrates a side view of a closure device 10 according to oneexample. The closure device 10 may include a handle 100, an outerhousing 110, a first plunger 120 coupled to a guide member 130, anoptional plug 140, a second plunger 150 coupled to a plurality of needlecarriers 160A, 160B, a plurality of detachable needles 170A, 170Bremovably coupled to the needle carriers 160A, 160B respectively, ananchor member 180 and control members 190A, 190B coupled to the anchormember 180.

The anchor member 180 and control members 190A, 190B may cooperate toallow the closure device 10 to be located relative to a puncture in avessel wall, such as an arteriotomy. Any type of locator having anyconfiguration may be used as desired to position the closure device 10in proximity to a vessel wall.

In the illustrated example, the control members 190A, 190B can bemanipulated to move the anchor member 180 between a pre-deployed state(not shown in FIG. 1A) to the expanded or deployed state shown in FIG.1A. In particular, the control members 190A, 190B may be coupled to theanchor member 180 and extend proximally from the anchor member 180through the plug 140, the guide member 130, the first plunger 120, andthe second plunger 150. In the illustrated example, manipulation of thecontrol members 190A, 190B may be performed manually, though it will beappreciated that any suitable device and/or method may be used tomanipulate the control members 190A, 190B.

As shown in FIG. 1B, the control members 190A, 190B and the anchormember 180 may form a continuous member. In such an example, retractingthe control members 190A, 190B may anchor the anchor member 180 againstan inner surface of a vessel wall or any other surface against which theanchor member 180 is positioned. In one embodiment, retracting bothcontrol members 190A, 190B simultaneously may produce tension or someother force in the anchor member 180 which may increase the resistanceof the anchor member 180 to contracting.

For example, the tension of both control members 190A, 190B may besimultaneously transferred to the anchor member 180 thereby creatingsufficient tension in the anchor member 180 to resist movement away fromits expanded configuration. In addition, providing an opposing forceagainst a proximal surface of the anchor member 180, such as with avessel wall, may also assist in creating sufficient tension in theanchor member 180 to resist contraction of the anchor member 180. In afurther implementation, the wires of the anchor member 180 may overlapor cross over each other in order to increase resistance.

In at least one example, retracting only one of the control members190A, 190B, may lessen the tension in the anchor member 180, therebyallowing the anchor member 180 to move from its deployed, expandedconfiguration to a contracted configuration. As a result, by retractingonly one of the control members 190A or 190B, without applying tensionto the other control member 190B or 190A or by applying a distal forceto the other control member 190B or 190A, the anchor member 180 maycontract and be retracted into the outer housing 110.

Referring again to FIG. 1A, the guide member 130 may be configured tohouse at least a portion of the control members 190A, 190B and to allowaxial movement of the control members 190A, 190B relative to the guidemember 130. Such a configuration may allow the control members 190A,190B to be manipulated at a proximal location to control the anchormember 180 at a distal location.

The guide member 130, and thus the control members 190A, 190B thatextend therethrough, may be at least partially housed within the outerhousing 110 and/or within the handle 100. As previously discussed, theguide member 130 may be coupled to the first plunger 120. Such aconfiguration may cause actuation of the first plunger 120 to result inaxial movement of the guide member 130. In at least one example, axialmovement of the first plunger 120 results in similar axial movement ofthe guide member 130. Such a configuration may allow the first plunger120 to extend and retract the guide member 130 from the outer housing110 as desired. While actuation of the first plunger 120 may have beendescribed with reference to axial movement of the first plunger 120relative to the handle 100, it will be appreciated that actuation of thefirst plunger 120 may include any type of action that results in desiredmovement of the guide member 130.

The optional plug 140 may be secured to the distal end of the guidemember 130 in such a manner that axial movement of the first plunger 120also results in a corresponding movement of the plug 140. Such aconfiguration may thereby allow axial movement of the first plunger 120to also extend and retract the plug 140 from the outer housing 110 asdesired by extending and retracting the guide member 130. Although theguide member 130 and the plug 140 are shown as moving together, it willbe appreciated that the plug 140 may also be independently controlledand moved, such as by the use of additional plungers and/or shafts.

In addition to serving as a mandrel to thereby move the plug, the guidemember 130 may also be configured to house the needle carriers 160A,160B and the detachable needles 170A, 170B. More specifically, the guidemember 130 may be configured to allow the needle carriers 160A, 160B andthe detachable needles 170A, 170B to move between a pre-deployed state(not shown in FIG. 1A) and the deployed state shown in FIG. 1A. In apre-deployed state (not shown in FIG. 1A), the needle carriers 160A,160B and/or the detachable needles 170A, 170B are retracted within theguide member 130. In the deployed state shown in FIG. 1A, the detachableneedles 170A, 170B and/or the needle carriers 160A, 160B extend radiallyand/or distally from the guide member 130.

The needle carriers 160A, 160B are coupled to the second plunger 150 insuch a way that actuation of the second plunger 150 causes the needlecarriers 160A, 160B to move between the pre-deployed and deployed statesdescribed above. In at least one example, axial movement of the secondplunger 150 relative to the first plunger 120 moves the needle carriers160A, 160B between the pre-deployed and deployed states. While actuationof the second plunger 150 may be provided by axial movement of thesecond plunger 150 relative to the first plunger 120, it will beappreciated that actuation of the second plunger 150 may include anytype of action that results in desired movement of the needle carriers160A, 160B.

As will be described in more detail, the actions described above allowthe closure device 10 to deploy the detachable needles 170A, 170B into avessel wall as part of a method for closing a puncture in the vesselwall. Exemplary structure of each of the components introduced abovewill first be introduced briefly followed by a discussion of theassembly and interaction of adjacent components. Thereafter, function ofan exemplary closure device will be discussed, followed by a discussionof an exemplary method of closing a puncture in a vessel wall.

FIG. 1B illustrates an exploded view of the closure device 10. Asillustrated in FIG. 1B, the handle 100 includes a distal end 100A and aproximal end 100B. A guide member receiving lumen 102 extends proximallyfrom the distal end 100A. A first plunger receiving lumen 104 extendsdistally from the proximal end 100B and is in communication with theguide member receiving lumen 102. In the illustrated example, a shoulder106 is formed at a transition between the guide member receiving lumen102 and the first plunger receiving lumen 104.

The outer housing 110 may be coupled to the distal end 100A of thehandle 100. In particular, the outer housing 110 may include a distalend 110A and a proximal end 110B. A guide member receiving lumen 112 maybe formed therein that extends through the distal end 110A and theproximal end 110B. The guide member receiving lumen 112 may beconfigured to allow the guide member 130 to move axially within theouter housing 110 as will be described in more detail hereinafter. In atleast one example, the guide member receiving lumen 112 may haveapproximately the same size as the guide member receiving lumen 102defined in the handle 102.

As shown in FIG. 1B, the proximal end 110B of the outer housing 110A maybe coupled to the distal end 100A of the handle 100 in such a mannerthat the guide member receiving lumens 102, 112 are aligned to therebyform a single lumen that is in communication with the distal end 110A ofthe outer housing 110 and the first plunger receiving lumen 104 in thehandle 100. Such a configuration may allow the first plunger 120 to moveaxially relative to the handle 100 while moving the guide member 130axially relative to outer housing 110 and the handle 100.

More specifically, the first plunger 120 may include a distal end 120Aand a proximal end 120B. The distal end 120A may be sized to fit withinthe first plunger receiving lumen 104. In the example shown, proximaltranslation of the first plunger 120 relative to the handle 100 may belimited by engagement between the distal end 120A of the first plunger120 and the shoulder 106 in the handle 100.

As previously introduced, the first plunger 120 may be coupled to theguide member 130. In particular, the distal end 120A of the firstplunger 120 may be coupled to a proximal end 130B of the guide member130. Accordingly, as the first plunger 120 moves proximally relative tothe handle 100, the proximal end 130B of the guide member 130 also movesproximally relative to the handle 100 as well as to the outer housing110. In at least one example, axial movement of the proximal end 130B ofthe guide member 130 results in a proportional or similar movement of adistal end 130A. This may allow an operator to move the first plunger120 axially to cause the distal end 130A of the guide member 130 to movebetween a first position, in which the distal end 130A is retractedwithin the distal end 110A of the outer housing 110, and various otherpositions, in which the distal end 130A extends beyond the distal end110A of the outer housing 110 to varying extents. The distal end 130A ofthe guide member 130 can be extended distally beyond the distal end 110Aof the outer housing 110 to deploy the plug 140 and/or position theneedle carriers 160A, 160B for deployment. Deployment of the plug 140will first be discussed, followed by a discussion of the deployment ofthe needle carriers 160A, 160B.

As previously introduced, the plug 140 may be coupled to the distal endof the guide member 130. As a result, the plug 140 may be retractedwithin and extended from the distal end 110A of the outer housing 110 byaxial movement of the first plunger 120.

In at least one example, the plug 140 may be formed of an expandablematerial. Suitable materials can include, without limitation, collagenand/or one or more polymers such as PEG. When the plug 140 is moved outof the outer housing 110, the plug 140 may move toward an expandedstate. Similarly, when the plug 140 is retracted back into the outerhousing 110, the plug 140 may be compressed to fit within the outerhousing 110. Accordingly, the distal end 130A of the guide member 130can be extended beyond the distal end 110A of the outer housing 110 todeploy the plug 140 and/or retracted within the outer housing 110 toretrieve the plug 140.

The distal end 130A of the guide member 130 can also be extended beyondthe distal end 110A to allow for deployment of the needle carrier 160A,160B. In particular, relative movement between the second plunger 150and the first plunger 120 may move the needle carriers 160A, 160Bbetween retracted and extended positions relative to the guide member130. The configuration of the guide member 130 will first be discussedin more detail, followed by a discussion of the interaction of the guidemember 130 and the needle carriers 160A, 160B.

FIG. 1C illustrates a cross-sectional view of the first plunger 120 andthe guide member 130. As shown in FIG. 1C, the first plunger 120 has asecond plunger receiving recess 124 defined therein that extendsdistally from a proximal end 120B. The first plunger 120 also has needlecarrier lumens 126A, 126B defined therein that extend proximally fromthe distal end 120A and into communication with the second plungerreceiving recess 124. A shoulder 128 is formed at a junction of theneedle carrier lumens 126A, 126B and the second plunger receiving recess124.

The guide member 130 may also have needle carrier lumens 132A, 132Bdefined therein that extend distally from the proximal end 130B. In theillustrated example, the needle carrier lumens 132A, 132B includeparallel or axially aligned portions 134A, 134B and curved, angledportions 136A, 136B that are in communication with openings 138A, 138Bin the guide member 130. The axially aligned portions 134A, 134B arealigned with the needle carrier lumens 126A, 126B defined in the firstplunger 120 to thereby form continuous lumens that extend from near thedistal end 130A of the guide member 130 to the second plunger receivingrecess 124 in the first plunger member 120. The configuration of theguide member 130 can allow the guide member 130 to house the needlecarriers 160A, 160B (FIG. 1B) therein prior to deployment and to guidethe needle carriers 160A, 160B radially outward and distally away fromthe guide member 130. An exemplary configuration of the needle carriers160A, 160B will first be discussed, followed by the interaction betweenthe needle carriers 160A, 160B and the guide member 130 with referenceto FIG. 1B.

As shown in FIG. 1B, proximal ends 162A, 162B of the needle carriers160A, 160B may be coupled to a distal end 150A of the second plunger 150in such a way that axial movement of the second plunger 150 results insimilar movement of the needle carriers 160A, 160B, including distalends 164A, 164B. As a result, when the second plunger 150 is positionedat least partially within the second plunger receiving lumen 124, theneedle carriers 160A, 160B extend through the first plunger 120 by wayof the needle carrier lumens 126A, 126B and into the guide member 130 byway of needle carrier lumens 132A, 132B.

The distal ends 164A, 164B of the needle carriers 160 A, 160B may bepositioned such that axial movement of the second plunger 150 relativeto the first plunger 120 moves the needle carriers 160A, 160B betweenretracted and extended positions relative to the guide member 130. Whenthe needle carriers 160A, 160B are retracted, the distal ends 164A, 164Bof the needle carriers 160A, 160B may be positioned proximally and/orradially inward relative to the openings 138A, 138B. When the needlecarriers 160A, 160B are extended, the distal ends 164A, 164B extend bothradially outward and distally away from the openings 138A, 138B in theguide member 130. Accordingly, the guide member 130 is configured tohouse the needle carriers 160A, 160B and to guide the needle carriers160A, 160B between the retracted and extended positions described above.

In at least one example, guide member 130 can be used to initiallyposition the anchor member 180. Further, the guide member 130 may beconfigured to house the control members 190A, 190B in addition to theneedle carriers 160A, 160B. FIG. 1D illustrates a cross-sectional viewof the closure device 10 taken along section 1D-1D of FIG. 1A. As shownin FIG. 1D, the control member lumens 139A, 139B may be defined in theguide member 139A, 139B to pass through the guide member 130. Thecontrol member lumens 139A, 139B may be positioned at any location andorientation desired. FIG. 1D also illustrates that the needle carriers160A, 160B may have suture lumens 166A, 166B defined therein. The suturelumens 166A, 166B may house sutures (not shown), which may be coupled tothe detachable needles 170A, 170B (FIG. 1B). As will be discussed inmore detail below, the closure device 10 may be configured to deploy thedetachable needles 170A, 170B (FIG. 1B) through a vessel wall as part ofa method for closing a puncture in a vessel wall. The function of theclosure device 10 will first be described in isolation, followed by adiscussion of the method for closing a puncture in a vessel wall usingthe closure device.

FIGS. 2A-2C are cross-sectional views of the closure device 10 atvarious positions taken along section 2-2 of FIG. 1A. In particular,FIG. 2C is a cross-section view of the closure device 10 in the deployedstate shown in FIG. 1A while FIGS. 2A and 2B show the closure device ina pre-deployed state and a location state according to one example. Forease of reference, various components will be described in which onecomponent is being moved toward a second component. It will beappreciated that a second member can also be moved toward the firstmember or some combination of movement of the two can also be used toaccomplish the same function.

As shown in FIG. 2A, while in a pre-deployed state the first plunger 120is drawn proximally from the handle 100 to thereby position the distalend 130A of the guide member 130 as well as the plug 140 within theouter housing 110. While the plug 140 is thus positioned within theouter housing 110, the plug 140 may be compressed (FIG. 1B). Further,the second plunger 150 may be positioned proximally from the firstplunger 120 to thereby position the distal ends 160A, 160B of the needlecarriers 160A, 160B within the guide member 130. As also shown in FIG.2A, the control members 190A, 190B may be manipulated and positioned tomove the anchor member 180 to a pre-deployed position within the outerhousing 110.

The closure device 10 may be moved from the pre-deployed state shown inFIG. 2A to the locator state shown in FIG. 2B by manipulating thecontrol members 190A, 190B and moving the first plunger 120 toward thehandle 100. In at least one example the second plunger 150 may move withthe first plunger 120 as the first plunger 120 moves toward the handle100. Such a configuration may allow the second plunger 150 to deploy theneedle carriers 160A, 160B separately from movement of the first plunger120.

As shown in FIG. 2B, as the first plunger 120 moves toward the handle100, the anchor member 180, the plug 140 and/or the distal end 130A ofthe guide member 130 move distally from the distal end of the outerhousing 110. The anchor member 180 may then be manipulated by thecontrol members 190A, 190B to move to the deployed state shown in FIG.2B.

More specifically, the anchor member 180 may be configured to move froman initial, contracted configuration within the outer housing 110 to adeployed, expanded configuration once deployed from the outer housing110. To facilitate movement from an initial, contracted configuration toa deployed, expanded configuration, the anchor member 180 may includeone or more superelastic or shape memory materials such as shape memoryalloys.

For example, the anchor member 180 may be heat set in a deployed,expanded configuration. The anchor member 180 may then be elasticallydeformed into an initial, contracted configuration contracted anddisposed within the outer housing 110. In its initial, contractedconfiguration shown in FIG. 2A, the anchor member 180 may storesufficient energy to return to its deployed, expanded configuration oncereleased from the outer housing 110 shown in FIG. 2B.

Retracting the handle 100 in a proximal direction may position and/oranchor the anchor member 180 against a distal or inner surface of avessel wall. In a further embodiment, further retracting the plungermember 130 in a proximal direction may retract the anchor member 180from the vessel and/or into the outer housing 110.

Once the anchor member 180 is at a desired position, the first plunger120 can be moved toward the handle 100 while holding the control members190A, 190B stationary to thereby the advance the plug 140 toward theanchor member 180. The plug 140, which may have expanded from thecompressed state described above upon exiting the outer housing 110, canthus be positioned relative to the anchor member 180. Such aconfiguration can allow the closure device 10 to engage a proximal orouter surface of the vessels walls of varying thicknesses as the plug140 can be advanced until it engages a vessel wall since the anchormember 180 is positioned on an opposing side of the vessel wall. Such aconfiguration can also place the distal end 130A of the guide member 130in position to deploy the needle carriers 160A, 160B.

As shown in FIG. 2C, the needle carriers 160A, 160B can be deployed bymoving the second plunger 150 toward the first plunger 120. As thesecond plunger 150 moves toward the first plunger 120, the needlecarriers 160A, 160B, and the distal ends 164A, 164B in particular, movethe detachable needles 170A, 170B distally and radially away from thedistal end 130A of the guide member 130. Such a configuration can allowthe detachable needles 170A, 170B to be moved into engagement with avessel wall, as part of an exemplary method for closing a puncture in avessel wall, which will now be discussed in more detail with referenceto FIG. 3A-3D.

FIG. 3A illustrates first steps of a method for closing a puncture 300in a vessel wall 310. For ease of reference, only the distal portion ofthe closure device 10 is shown and described. It will be appreciatedthat the distal components can be manipulated by proximal components ina similar manner as described above with reference to FIGS. 1A-2C.

Referring now to FIG. 3A, the method can begin by positioning a distalend 110A of the outer housing 110 in proximity with the puncture 300while the closure device 10 is in a pre-deployed state. With the distalend 110A of the outer housing 110 in proximity with the puncture 300,the anchor member 180 can be passed through the puncture 300 and movedto the deployed, expanded position as shown in FIG. 3B.

As shown in FIG. 3C, the anchor member 180 can then be drawn proximallyinto engagement with an inner surface or posterior side 310A of thevessel wall 310 adjacent the puncture 300 and the distal end 130A of theguide member 130 can be urged distally toward the outer surface oranterior side 310B of the vessel wall 310, thereby positioning thevessel wall 310 adjacent the puncture 300 between the plug 140 and theanchor member 180. With the vessel wall 310 positioned between theanchor member 180 and the plug 140, the vessel wall 310 can be describedas being located by the closure device 10 since the position of vesselwall 310 is established as being between the plug 140 and the anchormember 180. In at least one example, the expanded plug 140 can cover thepuncture 300 while pressure between the plug 140 and the anchor membercan provide sufficient contact between the plug 140 and the vessel wall310 to limit the flow of fluid from the puncture 300.

As also shown in FIG. 3C, when the guide member 130 is in position withrespect to the vessel wall 310, the distal end 130A of the guide member130 can be positioned distally of the distal end 110A of the outerhousing 110 to thereby expose the openings 138A, 138B (FIG. 1C) fromwithin the outer housing 110. With the openings 138A, 138B (FIG. 1C)thus exposed, the needle carriers 160A, 160B and detachable needles170A, 170B can be moved distally beyond and radially outward from thedistal end 130A of the guide member 130 to move the detachable needles170A, 170B at least partially through the vessel wall 310 on opposingsides of the puncture 300. As shown, the anchor member 180 in theexpanded state can extend beyond the position of the detachable needles170A, 170B in the vessel wall 310. Such a configuration can improve theability of the anchor member 180 to support user pullback by increasingthe area over which the anchor member 180 engages the inner surface ofthe vessel wall 300. In addition, the loop-type configuration of theanchor member 180 in the expanded state can allow the anchor member 180to locate the vessel wall 310 without substantial interference from thedetachable needles 170A, 170B. While the anchor member 180 in theexpanded state is shown extending beyond the position of the detachableneedle 170A, 170B, any size and/or configuration of the anchor member180 that is suitable to support user pullback against the vessel wall310 is possible. In one embodiment, the anchor member 180 in theexpanded state can extend between the position of the detachable needles170A, 170B and the sides of the puncture 300. In other embodiments, theanchor member 180 in the expanded state can extend considerably beyondthe position of the detachable needles 170A, 170B.

FIG. 3D shows the detachable needle 170A in more detail. While a singledetachable needle 170A is shown in FIG. 3D, it will be appreciated thatthe discussion of the detachable needle 170A can be equally applicableto the detachable needle 170B (FIG. 3C) as well as any number of otherdetachable needles. As shown in FIG. 3D, the detachable needle 170A mayinclude features that allow it to readily pierce the vessel wall 310while resisting retraction therefrom. In particular, the detachableneedle 170A includes a generally conical body 172 having a tip 174 and abase 176. The detachable needle 170A may also include a shaft 178coupled to the base 178.

In at least one example, the shaft 178 is configured to have a suture320 coupled thereto. The shaft 178 can be further configured to bepositioned within the suture lumen 166A to provide a slip fit betweenthe needle carrier 160A and the shaft 178. The shaft 178 may also have anarrower aspect than the base 176. Such a configuration allows theneedle carrier 160A to exert a distally acting force on the detachableneedle 170A by way of the base 176. Such a distally acting force cancause the tip 174 to pierce the vessel wall 310 while the width of thebase 176 anchors the detachable needle 170A to the vessel wall 310 andresists proximal retraction.

Referring again to FIG. 3C, once the detachable needles 170A, 170B areanchored in the vessel wall 310, the needle carriers 160A, 160B can bedrawn proximally into the guide member 130. The engagement between thedetachable needles 170A, 170B and the vessel wall 310 can be sufficientto detach the detachable needles 170A, 170B from the needle carriers160A, 160B as the needle carriers 160A, 160B are withdrawn.

After the needle carriers 160A, 160B are drawn into the guide member130, one of the control members 190A, 190B can be moved in one directionmore than the other of the control members 190A, 190B to move the anchormember 180 into a contracted or collapsed state. The guide member 130,the plug 140, and the control member 180 can then be drawn into theouter housing 110. Thereafter, the closure device 10 can be withdrawn,leaving the detachable needles 170A, 170B engaged in the vessel wall 310with the sutures 320 extending proximally from the detachable needles170A, 170B as shown in FIG. 3E.

As also shown in FIG. 3E, a constrictor 330 can be passed over thesutures 320. The constrictor 330 can have a smaller diameter than thedistance between the detachable needles 170A, 170B. As a result, movingthe constrictor 330 over the sutures 320 while maintaining tension onthe sutures 320 can act to draw the detachable needles 170A, 170B towardeach other, thereby pulling the puncture 300 closed, as shown in FIG.3E.

Once the puncture 300 is sufficiently closed, the constrictor 330 can besecured to maintain tension in the sutures 320 between the detachableneedles 170A, 170B and the constrictor 330. For example, in oneembodiment the constrictor 330 can be an annular member that can becrimped to maintain the tension in the sutures 320. While an annularmember can be used, it will be appreciated that any constrictor can beused to establish tension in the sutures 170A, 170B. It will also beappreciated that any suitable means may also be used to maintain thetension in the sutures 170A, 170B. Thereafter, the sutures 170A, 170Bcan be trimmed as desired using any appropriate method and/or device.

Accordingly, as shown in FIGS. 1A-3E, the closure device 10 can beconfigured to deploy detachable needles 170A, 170B in a vessel wall 310.A constrictor 330 can then be used to establish tension in sutureextending away from the detachable needles 170A, 170B to thereby closethe puncture 300 in the vessel wall 310. In the illustrated example, twoneedle carriers 160A, 160B and detachable needles 170A, 170B have beendescribed. It will be appreciated that in other examples, any number ofneedle carriers and detachable needles can be used, include four or moreneedle carriers and detachable needles.

In the example shown above, the detachable needles included a conicalshape in which the sutures are anchored in a vessel wall by engagementwith a proximal portion of the detachable needle. FIG. 4 illustrates oneconfiguration for a detachable needle 340. The detachable needle 340 canhave a body 350 having a tapered point 360. A suture 320 can bepositioned in a manner that causes the detachable needle 340 to rotatewhen tension is applied to the suture 320 to thereby cause a lateralportion of the detachable needle 340 to engage a vessel wall to therebyanchor the detachable needle 340 thereto. For example, the suture 320can be offset either radially from a center axis 370 of the detachableneedle 340 and/or distally from a proximal end 380 of the body 350.

FIGS. 5A-6B illustrate a vessel closure device 40 according to oneexample. The closure device 40 may be similar in many respects to theclosure device 10 previously described above in FIGS. 1A-4, whereincertain features will not be described in relation to this configurationwherein those components may function in the manner as described aboveand are hereby incorporated into this additional configuration describedbelow. As shown in FIG. 5A, the closure device 40 may include an outersheath 410 having a distal end with a tapered tip portion 420. Thetapered tip portion 420 may be formed of a polymer or any other suitablebiocompatible material. The tapered tip portion 420 may be coupled tothe outer sheath 410 or may be integrally formed on the outer sheath410. In one embodiment, the tapered tip portion 420 may include slitsradially spaced about the tapered tip portion 420 and extendingproximally from a distal end of the tapered tip portion 420. The slits430 may define intermediate portions of the tapered tip portion 420,each intermediate portion having a free end and a fixed end. The slits430 may be elongated, triangular, diamond shaped, oval, or any otherconfiguration and/or shape suitable to define the intermediate portionsof the tapered tip portion 420. As shown in FIG. 5B, the slits 430 mayallow the intermediate portions of the tapered tip portion 420 to expandor open up as a guide member 490, a plug 440, an anchor member 480, orneedle guides 460A, 460B and detachable needles 470A, 470B are advancedfrom within the outer sheath 410. Such a configuration can help protectthe guide member 490, the plug 440, the anchor member 480, the needleguides 460A, 460B and the detachable needles 470A, 470B, and/or theaccess tract. For example, the tapered tip portion 420 may help protectthe access tract from damage that may be caused by the guide member 490,the plug 440, the anchor member 480, the needle guides 460A, 460B andthe detachable needles 470A, 470B by enclosing them within the outersheath 410 up until immediately adjacent a puncture 300. In addition,enclosing the same components within the outer sheath 410 up untilimmediately adjacent the puncture may help protect and improve theimplementation of the guide member 490, the plug 440, the anchor member480, the needle guides 460A, 460B and the detachable needles 470A, 470Bby limiting interference from the access tract and/or other biologicalmaterials. Moreover, the conical shape of the tapered tip portion 420can help ease advancement of the outer sheath 410 through the accesstract.

FIGS. 6A and 6B illustrate the tapered tip portion 420 in a firstconfiguration and an expanded or open configuration over a puncture in avessel wall 310. As shown in FIG. 6A, the distal portion of the outersheath 410 may be advanced through the access tract and the tapered tipportion 420 may be positioned slightly within the puncture 300. With thetapered tip portion 420 positioned in the puncture 300, the anchormember 480 can be passed directly into the puncture 300. The anchormember 480 can then be moved to a deployed expanded position as shown inFIG. 6B. The guide member 490 and plug 440 can then be urged through thetapered tip portion 420 and distally toward an outer surface of a vesselwall 310. As shown in FIG. 6B, urging the guide member 490 and the plug440 through the tapered tip portion 420 can rotate the intermediateportions of the tapered tip portion 420 about pivot points 495 which inturn can cause the tapered tip portion 420 to expand or open up. Inother embodiments, the intermediate portions of the tapered tip portion420 can be flexed outward by the plug 440 and/or the guide member 490 tocause the tapered tip portion to expand or open up. In one embodiment,once the plug 440 and the anchor member 480 are positioned on oppositesides of the vessel wall 310, the outer housing 410 may be retracteddistally a predetermined distance to allow for deployment of the needleguides 460A, 460B and the detachable needles 470A, 470B from the guidemember 490.

Accordingly, as shown in FIGS. 5A-6B, the tapered tip portion 420 of theclosure device may be configured to ease the advancement of the closuredevice 40 through an access tract; aid in the protection of the accesstract, the closure device 40 and components thereof; and improveimplementation of the closure device's components within the accesstract.

Embodiments of the anchor, detachable needles and the like may include amaterial made from any of a variety of known suitable biocompatiblematerials, such as a biocompatible shape memory material (SMM). Forexample, the SMM may be shaped in a manner that allows for a deliveryorientation while within the tube set, but may automatically retain thememory shape of the detachable needles once deployed into the tissue toclose the opening. SMMs have a shape memory effect in which they may bemade to remember a particular shape. Once a shape has been remembered,the SMM may be bent out of shape or deformed and then returned to itsoriginal shape by unloading from strain or heating. Typically, SMMs maybe shape memory alloys (SMA) comprised of metal alloys, or shape memoryplastics (SMP) comprised of polymers. The materials may also be referredto as being superelastic.

Usually, an SMA may have an initial shape that may then be configuredinto a memory shape by heating the SMA and conforming the SMA into thedesired memory shape. After the SMA is cooled, the desired memory shapemay be retained. This allows for the SMA to be bent, straightened,twisted, compacted, and placed into various contortions by theapplication of requisite forces; however, after the forces are released,the SMA may be capable of returning to the memory shape. The main typesof SMAs are as follows: copper-zinc-aluminum; copper-aluminum-nickel;nickel-titanium (NiTi) alloys known as nitinol; nickel-titaniumplatinum; nickel-titanium palladium; and cobalt-chromium-nickel alloysor cobalt-chromium-nickel-molybdenum alloys known as elgiloy alloys. Thetemperatures at which the SMA changes its crystallographic structure arecharacteristic of the alloy, and may be tuned by varying the elementalratios or by the conditions of manufacture. This may be used to tune thedetachable needles so that it reverts to the memory shape to close thearteriotomy when deployed at body temperature and when being releasedfrom the tube set.

For example, the primary material of an anchor, detachable needles,and/or ring may be of a NiTi alloy that forms superelastic nitinol. Inthe present case, nitinol materials may be trained to remember a certainshape, retained within the tube set, and then deployed from the tube setso that the tines penetrate the tissue as it returns to its trainedshape and closes the opening. Also, additional materials may be added tothe nitinol depending on the desired characteristic. The alloy may beutilized having linear elastic properties or non-linear elasticproperties.

An SMP is a shape-shifting plastic that may be fashioned into adetachable needles in accordance with the present disclosure. Also, itmay be beneficial to include at least one layer of an SMA and at leastone layer of an SMP to form a multilayered body; however, anyappropriate combination of materials may be used to form a multilayereddevice. When an SMP encounters a temperature above the lowest meltingpoint of the individual polymers, the blend makes a transition to arubbery state. The elastic modulus may change more than two orders ofmagnitude across the transition temperature (Ttr). As such, an SMP maybe formed into a desired shape of an endoprosthesis by heating it abovethe Ttr, fixing the SMP into the new shape, and cooling the materialbelow Ttr. The SMP may then be arranged into a temporary shape by forceand then resume the memory shape once the force has been released.Examples of SMPs include, but are not limited to, biodegradablepolymers, such as oligo(ε-caprolactone)diol, oligo(p-dioxanone)diol, andnon-biodegradable polymers such as, polynorborene, polyisoprene, styrenebutadiene, polyurethane-based materials, vinyl acetate-polyester-basedcompounds, and others yet to be determined. As such, any SMP may be usedin accordance with the present disclosure.

An anchor, detachable needles, ring and the like may have at least onelayer made of an SMM or suitable superelastic material and othersuitable layers may be compressed or restrained in its deliveryconfiguration within the garage tube or inner lumen, and then deployedinto the tissue so that it transforms to the trained shape. For example,a detachable needles transitions to close the opening in the body lumenwhile an anchor may expand to anchor the closure device.

Also, the anchor, detachable needles, ring, or other aspects orcomponents of the closure device may be comprised of a variety of knownsuitable deformable materials, including stainless steel, silver,platinum, tantalum, palladium, nickel, titanium, nitinol, nitinol havingtertiary materials (U.S. 2005/0038500, which is incorporated herein byreference, in its entirety), niobium-tantalum alloy optionally dopedwith a tertiary material (U.S. 2004/0158309, 2007/0276488, and2008/0312740, which are each incorporated herein by reference, in theirentireties) cobalt-chromium alloys, or other known biocompatiblematerials. Such biocompatible materials may include a suitablebiocompatible polymer in addition to or in place of a suitable metal.The polymeric detachable needles may include biodegradable orbioabsorbable materials, which may be either plastically deformable orcapable of being set in the deployed configuration.

In one embodiment, the detachable needles, anchor, and/or ring may bemade from a superelastic alloy such as nickel-titanium or nitinol, andincludes a ternary element selected from the group of chemical elementsconsisting of iridium, platinum, gold, rhenium, tungsten, palladium,rhodium, tantalum, silver, ruthenium, or hafnium. The added ternaryelement improves the radiopacity of the nitinol detachable needles. Thenitinol detachable needles has improved radiopacity yet retains itssuperelastic and shape memory behavior and further maintains a thin bodythickness for high flexibility.

In one embodiment, the anchor, detachable needles, and/or ring may bemade at least in part of a high strength, low modulus metal alloycomprising Niobium, Tantalum, and at least one element selected from thegroup consisting of Zirconium, Tungsten, and Molybdenum.

In further embodiments, the detachable needles, anchor, and/or ring maybe made from or be coated with a biocompatible polymer. Examples of suchbiocompatible polymeric materials may include hydrophilic polymer,hydrophobic polymer biodegradable polymers, bioabsorbable polymers, andmonomers thereof. Examples of such polymers may include nylons,poly(alpha-hydroxy esters), polylactic acids, polylactides,poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide,polyglycolic acids, polyglycolide, polylactic-co-glycolic acids,polyglycolide-co-lactide, polyglycolide-co-DL-lactide,polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides,polyesters, polyorthoesters, polycaprolactones, polyesters,polyanydrides, polyphosphazenes, polyester amides, polyester urethanes,polycarbonates, polytrimethylene carbonates,polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates),polyfumarates, polypropylene fumarate, poly(p-dioxanone),polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines,poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids,polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols,polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcoholcopolymers, ethylenevinylalcohol copolymers (EVAL),propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP),combinations thereof, polymers having monomers thereof, or the like.

In yet a further embodiment, a closure device 50 may include needleguides that can be deployed from the closure device 50 at varyingangles. The closure device 50 may be similar in many respects to theclosure devices 10 and 40 previously described above in FIGS. 1A-6B,wherein certain features will not be described in relation to thisconfiguration wherein those components may function in the manner asdescribed above and are hereby incorporated into this additionalconfiguration described below.

FIG. 7A shows a side view of the closure device 50. As shown, theclosure device 50 may include a guide member 520, needle guides 510A,510B deployable from the guide member 520, a needle guide activationhandle 620 coupled to the needle guides 510A, 510B, and an angleadjustment member 630 movably attached to the guide member 520. FIG. 7Bshows the needle guides 510A, 510B removed from the closure device 50.While features of a single needle guide 510A are discussed, it will beappreciated that any discussion of the features of the needle guide 510Acan be equally applicable to the features of the needle guide 510B aswell as any number of other needle guides.

The needle guides 510A, 510B may comprise a substantially flexible orsemi-rigid body 530 having a proximal portion 540 and a distal portion550. The proximal portions 540 are substantially parallel to or axiallyaligned with one another, whereas the distal portions 550 of the needleguides 510A, 510B may be angled or curved to extend laterally outwardfrom the proximal portions 540. In one embodiment, the distal portions550 of the needle guides 510A, 510B may be self-biased to extendlaterally outward from the proximal portions 540. In another embodiment,the needle guides 510A, 510B may have a memory shape where the distalportions 550 extend laterally outward from the proximal portions 540.The needle guides 510A, 510B can be configured such that the needleguides 510A, 510B can be forcibly straightened but return to theircurved or angled shape upon release from external forces.

As discussed in more detail below, the design of the needle guides 510A,510B allows the angle adjustment member 630 to be configured to adjust adeployment angle “α” of the needle guides 510A, 510B. The deploymentangle “α” is defined as the greatest acute angle between the needleguides 510A, 510B and a longitudinal axis of the guide member 520. Inone configuration, the deployment angle “α” is in a range between about20 degrees and about 60 degrees, while in another configuration thedeployment angle “α” is between about 30 degrees and 50 degrees. Oneskilled in the art will understand that the deployment angle “α” canrange between any puncture angle commonly used to suture an body lumenopening. Adjusting the deployment angle “α” allows the closure device 50to be used on body lumen openings of varying sizes.

It will be understood by those skilled in the art that various otherconfigurations of the needle guides 510A, 510B are possible. Forexample, although the needle guides 510A, 510B have at least an angledor curved portion 545, the body 530 of the needle guides 510A, 510Bbeing entirely curved or substantially angled is possible. Moreover, theneedle guides 510A, 510B may include a substantially rigid portion, aflexible portion and/or a semi-rigid portion. The needle guides 510A,510B may be comprised of a biocompatible material such as one or morepolymers, elastomers, plastics, metals, composites, other similarmaterials, or any combination thereof. The needle guides 510A, 510B mayalso include one or more superelastic or shape memory materials such asshape memory alloys. The needle guides 510A, 510B may have across-sectional configuration that is rectangular, circular, elliptical,triangular, uniform, varying, substantially solid, substantially hollow,or any other cross-sectional configuration suitable for deploymentthrough a vessel wall (not shown in FIG. 7A). In one embodiment, theneedle guides 510A, 510B may be configured to hold a suture (not shown)and/or a suture securing device (not shown). For example, the needleguides 510A, 510B can include a suture lumen 560 defined between theproximal portion 540 and the distal portion 550. The suture lumens 560can be sized, shaped and/or configured to hold the suture and/or thesuture securing device. Further, although two needle guides 510A, 510Bare shown, one needle guide or a plurality of needle guides is possible.The needle guides 510A, 510B can also be configured to form apenetration path though a vessel wall 570 immediately surrounding a bodylumen opening. As shown, the distal portion 550 of the needle guides510A, 510B may include a penetrator tip 580. In another embodiment, theneedle guides 510A, 510B may include a detachable penetrator tipdisposed on the distal portion 550. In a further example, the penetratortip 580 may comprise one or more sharpened edges on the distal portion550 of the needle guides 510A, 510B.

As illustrated in FIG. 7A, the needle guides 510A, 510B can extendlongitudinally along the length of the guide member 520 toward openings610A, 610B near the distal end 670 of the guide member 520 (as shown byhidden lines in FIG. 7A). While the needle guides 510A, 510B are showndisposed within the guide member 520, the needle guides 510A, 510Bdisposed on the guide member 520 are possible. For example, the needleguides 510A, 510B may be positioned in between the outer surface of theguide member 520 and the inner surface of the angle adjustment member630 in longitudinal grooves (not shown) formed on the outer surface ofthe guide member 520.

The needle guide activation plunger or handle 620 can be coupled to theneedle guides 510A, 510B such that movement of the needle guideactivation handle 620 can deploy the needle guides 510A, 510B thoughopenings the 610A, 610B and distally of the guide member 520. While aneedle activation plunger or handle is shown, any number of mechanismscan deploy the needle guides 510A, 510B distally of the guide member 520such as a release button, a trigger, an actuator, or other mechanismscapable of deploying the needle guides 510A, 510B.

The angle adjustment member 630 may include a proximal end 640 and adistal end 650 and concentrically surround the guide member 520. Theangle adjustment member 630 can be configured to support the needleguide activation handle 620 and move relative to the length of the guidemember 520. In another embodiment, the guide member 520 may moverelative to the angle adjustment member 630. The angle adjustment member630 may be further configured so that the angle adjustment member 630can adjust the deployment angle “α” of the needle guides 510A, MOB.While the angle adjustment member 630 is shown as a sheath, the angleadjustment member 630 may comprise elongate members moveably attached toopposing sides of the guide member 520, or an annular member moveablyattached to the guide member 520 having one or more deflector rodsaligned with the openings 610A, 610B, or any other configurationsuitable to adjust the deployment angle “α” of the needle guides 510A.

FIGS. 8A-8D are cross-sectional views of the closure device 50 taken atvarious positions along section 6-6 of FIG. 7A to illustrate adjustmentof the deployment angle “α” by the angle adjustment member 630. As shownin FIG. 8A, while in a pre-deployed state the needle guides 510A, 510Bmay be positioned within the guide member 520. Again, while the needleguides 510A, 510B are shown disposed within the guide member 520, needleguides 510A, 510B disposed on the guide member 520 are possible. Asshown, the guide member 520 may include a plurality of lumens 660A, 660Bextending distally toward the openings 610A, 610B of the guide member520. The lumens 660A, 660B may be sized to receive at least one of theneedle guides 510A, 510B. The lumens 660A, 660B may extend parallel tothe longitudinal axis of the guide member 520. The needle guides 510A,510B may be forcibly straightened within the lumens 660A, 660B. Thisfacilitates low-profile storage of the needle guides 510A, 510B and theclosure device 10 generally. Moreover, storage of the needle guides510A, 510B within the lumens 660A, 660B can help prevent contaminationof the needle guides 510A, 510B.

The openings 610A, 610B may be aligned along the longitudinal axis ofthe guide member 520 and be in fluid communication with the lumens 660A,660B. As shown, the openings 610A, 610B may be located near a distal end670 of the guide member 520. Although the openings 610A, 610B in theguide member 520 are shown parallel to the longitudinal axis of theguide member 520, the openings 610A, 610B can be oriented at anydesirable angle relative to the guide member 520. For example, theopenings 610A, 610B may be oriented substantially non-parallel to thelongitudinal axis of the guide member 520 such that the openings 610A,610B direct the needle guides 510A, 510B radially away from the guidemember 520. Moreover, while the openings 610A, 610B are shown formed onthe end of the guide member 520, the openings 610A, 610B may be formedon the sidewalls of the guide member 520. The needle guides 510A, 510Bcan be advanced through the openings 610A, 610B by manipulation of theneedle guide activation handle 620 (not shown).

FIG. 8B shows the needle guides 510A, 510B deployed from the guidemember 520 with the angle adjustment member 630 in a retracted position.As shown, the angle adjustment member 630 can be advanced along andrelative to the guide member 520 such that the distal end 650 of theangle adjustment member 630 is positioned proximal to the openings 610A,610B in the guide member 520. Consequently, the needle guides 510A, 510Bmay form a penetration path through the vessel wall 570 without beingbiased toward the longitudinal axis of the guide member 520 by the angleadjustment member 630. With the angle adjustment member 630 in theretracted position, the primary deployment angle “α” of the needleguides 510A, 510B may be approximately 60 degrees relative to thelongitudinal axis of the guide member 520, as determined primarily bythe configuration of the needle guides 510A, 510B. The primarydeployment angle “α” minimizes the deployment depth, thereby minimizingthe possibility of overshooting the vessel. Moreover, the primarydeployment angle “α” maximizes the radial span of the needle guides510A, 510B, thereby maximizing the size of the body lumen opening theneedle guides 510A, 510B can close.

FIG. 8C shows the needle guides 510A, 510B deployed from the guidemember 520 with the angle adjustment member 630 positioned in anextended position. As shown, the angle adjustment member 630 can beadvanced along and relative to the guide member 520 until the distal end650 of the angle adjustment member 630 is distal of the openings 610A,610B. The angle adjustment member 630 may be substantially aligned orproximal to the distal end 670 of the guide member 520. In the extendedposition, the angle adjustment member 630 may deflect the needle guides510A, 510B toward the deployment angle “α” of approximately 20 degreesrelative to the guide member 520. With the angle adjustment member 630in the extended position, the needle guides 510A, 510B can close asmaller body lumen opening.

FIG. 8D shows the needle guides 510A, 510B deployed from the guidemember 520 with the angle adjustment member 630 positioned in anintermediate position. The intermediate position is defined between theretracted position and the extended position. In the intermediateposition, the angle adjustment member 630 may be advanced along andrelative to the guide member 520 such that the distal end 650 of theangle adjustment member 630 is positioned distal to the openings 610A,610B but proximal to the position of the angle adjustment member 630 inthe extended position. With the angle adjustment member 630 in theintermediate position, the angle adjustment member 630 may deflect theneedle guides 510A, 510B toward the deployment angle “α” between about20 degrees and about 60 degrees. Distal movement of the angle adjustmentmember 630 beyond the openings 610A, 610B will reduce the deploymentangle “α” toward about 20 degrees until the angle adjustment member 630reaches the extended position. Proximal movement of the angle adjustmentmember 630 beyond the openings 610A, 610B will increase the deploymentangle “α” toward about 60 degrees until the angle adjustment member 630reaches the retracted position. Thus, a user can adjust the deploymentangle of the needle guides 510A, MOB anywhere between about 20 degreesand about 60 degrees by moving the angle adjustment member 630 betweenthe retracted position and the extended position.

In another embodiment, the closure device 10, closure device 40, orclosure device 50 may employ an articulating suture securing devicehaving a low-profile configuration and an expanded configuration. FIG.9A shows a perspective view of a suture securing device 705 according toone example. As shown, the suture securing device 705 may comprise atubular body 710, a cutout 730 formed in the tubular body 710, and asuture 740 attached to the tubular body 710.

The tubular body 710 may be elongated and have a proximal end 715, anintermediate portion 720, and a distal end 725. The tubular body 710 caninclude a first opening 735 at the proximal end 715 for receiving an endof the suture 740. The suture 740 may extend into the interior of thetubular body 710 along its length. The suture 740 may exit the tubularbody 710 through a second opening 745 located near the distal end 725.While the suture 740 is shown exiting the tubular body through thesecond opening 745 located near the distal end 725, the suture 740 mayexit the tubular body 710 at any number of locations. For example, asecond opening may be located near the intermediate portion 720 of thetubular body 710 such that the suture may exit the tubular body 710 nearthe intermediate portion 720. In another example, a third opening (notshown) may be located between the intermediate portion 720 and thedistal end 725 such that the suture 740 may exit through the thirdopening.

The tubular body 710 may be crimped, as shown at 780, about the suture740 to mechanically affix the suture 740 to the suture securing device705. In other embodiments, the tubular body 710 can be crimped in aplurality of locations. In addition and or instead to mechanicalcrimping, the suture 740 may be bonded to the suture securing device 705using an adhesive, heat, fasteners, knots or the like. The tubular body710 may also include a swaged portion 750 adjacent the second opening745 to help retain the suture 740 in the tubular body 710. The tubularbody 710 may include any number of rigid or semi-rigid materials. Forexample, the tubular body 710 may include one or more polymers,elastomers, plastics, metals, composites, other similar materials, orcombinations thereof. The tubular body 710 may also include one or moresuperelastic or shape memory materials such as shape memory alloys.

The cutout 730 may extend distally from the proximal end 715 of thetubular body 120. In other embodiments, more than one cutout 730 ispossible. While the cutout 730 is shown having being u-shaped, arectangular, triangular, elliptical, oval, or any other suitable shapeis possible. The cutout 730 may include a plurality of tissue-engagingelements 755 extending along each side of the cutout 730. In otherembodiments, the tissue-engaging elements 755 may also be formed onother portions of the tubular body 710. For example, the tissue-engagingelements 755 may be formed over the entire outer surface of the tubularbody. In a further example, the tissue-engaging elements 755 may beformed between the proximal end 715 and the intermediate portion 720 ofthe tubular body 710. In yet a further example, the tissue-engagingelements 755 may be formed between the proximal end 715 and the distalend 725 on the same surface as the cutout 730. In other embodiments, thecutout 730 may include one or more tissue-engaging elements.

The tissue-engaging elements 755 extend from opposing sides of thecutout 730 and may comprise teeth, serrations, tilted trapezoidalbodies, or any other shape or configuration suitable to increasefriction when engaged against a vessel wall. It will be apparent to oneskilled in the art that a variety of tissue-engaging elementconfigurations may be possible. For example, the tissue-engagingelements 755 may have tapered bodies. The tissue-engaging elements 755may have generally circular disc-shaped bodies. The tissue-engagingelements 755 may have setaceous bodies. The tissue-engaging elements 755may have hook shaped bodies. The tissue-engaging elements 755 may havetine shaped bodies. The tissue-engaging elements 755 may comprisenotches formed in the tubular body 710. The orientation of thetissue-engaging elements 755 may also vary. For example, thetissue-engaging elements 755 may be angled toward or away from thecutout 730. The tissue-engaging elements 755 may be curved inwardly oroutwardly relative to the cutout 730. The tissue-engaging elements 755may alternate between extending inward and outward from the cutout 730.

In another embodiment, at least a portion of the suture 740 may includefriction producing structures 760. The friction producing structures 760may include a plurality of annular vanes formed in the outer surface ofthe suture 740. In another embodiment, the friction producing structures760 may include raised helically formed or threaded portions on or inthe suture 740. In another embodiment, the friction producing structures760 may include one or more annular grooves formed in the suture 740. Inanother embodiment, the friction producing structures 760 may be formedon a substantially rigid portion of the suture 740. In a furtherembodiment, the friction producing structures 760 may be non-uniformlydistributed on the suture 740. In yet a further embodiment, the frictionproducing structures 760 may include a plurality of raised portions anda plurality of recessed portions.

FIGS. 9B and 9C show the suture securing device 705 in a low-profileconfiguration (FIG. 9B) and an expanded configuration (FIG. 9C). Asshown in FIG. 9B, the suture securing device 705 may have a low-profileconfiguration in which the tubular body 710 is substantially alignedalong the axis of the suture 740. The low-profile configuration shown inFIG. 9B facilitates storage and delivery of the suture securing device705. For example, a needle guide 765 may hold the suture securing device705 and the suture 740 as the needle guide 765 forms a penetration paththrough the vessel wall 770 immediately adjacent a body lumen opening.In another embodiment, the suture securing device 705 can be configuredto penetrate the vessel wall 770 rather than the needle guide 765. Forexample, the suture securing device 705 can be disposed on the needleguide 765 with a penetrator tip (not shown) attached to the distal end725 of the suture securing device 705.

As shown in FIG. 9C, the suture securing device 705 may have an expandedconfiguration. In one embodiment, the needle guide 765 may be retracteddepositing or releasing the suture securing device 705 distally of thevessel wall 770. The tubular body 710 may then rotate relative to thesuture 740 such that the suture 740 is received within the cutout 730and the tubular body 710 is positioned substantially non-parallel to thesuture 740 and substantially parallel to the vessel wall 770. In anotherembodiment, the tubular body 710 may include more than one cutoutconfigured to receive the suture 740 such that the tubular body 710 mayrotate relative to the suture 740 in a plurality of directions. Forexample, the tubular body 710 may include a second cutout (not shown)formed opposing the cutout 730 such that the tubular body 710 may rotateclockwise or counterclockwise about the suture 740. In a furtherembodiment, the cutout 730 may include a receptacle (not shown)configured to fix the orientation of the suture 740 relative to thetubular body 710 once the suture securing device 705 moves into theexpanded configuration. In yet a further embodiment, the cutout 730 mayinclude a locking clip (not shown) to fix the orientation of the suture740 relative to the tubular body 710 once the suture securing device 705moves into the expanded configuration. In yet a further embodiment, thecutout 730 may include a catch member (not shown) to fix the orientationof the suture 740 relative to the tubular body 710 once the suturesecuring device 705 moves into the expanded configuration.

Reference is now made to FIGS. 10A-10C which illustrates an additionalexample suture securing device 805. The suture securing device 805 maybe similar in many respects to the suture securing device 705 previouslydescribed above in FIGS. 9A-9C. To the extent features or components ofthis configuration function in a manner similar to that as describedabove, such disclosure is hereby incorporated into the followingadditional configuration. Like structures and/or components are givenlike reference numerals. Additionally, the suture securing device 805may incorporate at least one component of the suture securing device 705described in FIGS. 9A-9C.

As shown in FIG. 10A, the suture securing device 805 may include atubular body 810 having a proximal end 815, a mid-point 820, and adistal end 825. The tubular body 810 can include a first opening 835 atthe proximal end 815 for receiving an end of a suture 840. The suture840 may extend distally within the tubular body 810 along its length.The suture 840 can also exit the tubular body 810 through a secondopening 845 located near the distal end 825. As shown, the tubular body810 may be crimped 880 about the suture 840 near the distal end 825 tomechanically affix the suture 840 to the suture securing device 805. Inother embodiments, the tubular body 810 can be crimped in a plurality oflocations. In addition and or instead to mechanical crimping, the suture840 may be bonded to the suture securing device 805 using an adhesive,heat, fasteners, knots or the like. The tubular body 810 may alsoinclude a swaged portion 850 adjacent the second opening 845 to helpretain the suture 840 in the tubular body 710.

The tubular body 810 may include a plurality of elongated slots 897radially spaced about the tubular body, and extending distally from theproximal end 815. The slots 897 may define a plurality of projections875 therebetween. In one embodiment, each projection 875 may have awire, strip-like, or ribbon like shape with a fixed end 885 and a freeend 890. The projections 875 of the tubular body 810 may be formed byone of more strips of material. In one embodiment, the projections 875may include notches 895 formed near the free end 890. The notches 895may be sized, shaped, and configured to help anchor the projections 875against a vessel wall 870. In another embodiment, the projections 875may include tissue-engaging elements formed near the free end 890. Forexample, the projections 875 may include one or more teeth shapedelements, tines, and/or barbs that are oriented to engage the vesselwall 870. The free end 890 of the projections 875 may also be forkedsuch that the free end 890 can penetrate the vessel wall 870.

In one embodiment, the tubular body 810 may have four projections 875.In another embodiment, the tubular body 810 may have six projections875. In a further embodiment, the projections 875 may be spaced evenlyabout the tubular body 810. In a further embodiment, the projections 875may form a shape similar to an ‘x’. In yet further embodiment, thetubular body 810 may have multiple layers of projections 875. Forexample, the tubular body 810 may include a first set of projections 875a and a second set of projections 875 b. Each set may include any numberof projections 875 desired for a particular application. In furtherembodiments, each projection 875 may have any shape, size, orconfiguration desired for a particular application.

As shown in FIG. 10B, the suture securing device 805 may have acollapsed configuration in which the projections 875 are substantiallyparallel with a longitudinal axis of the tubular body 810. The collapsedconfiguration shown in FIG. 10B may facilitate storage and delivery ofthe suture securing device 805. A needle carrier 865 may hold the suturesecuring device 805 in the collapsed configuration as the needle carrier865 forms a penetration path through the vessel wall 870 immediatelyadjacent a body lumen opening. In another embodiment, the suturesecuring device 805 can be configured to penetrate the vessel wall 870rather than the needle guide 865. For example, the suture securingdevice 805 can be disposed on the needle guide 865 with a penetrator tip(not shown) attached to the distal end 825 of the suture securing device805.

As shown in FIG. 10C, the suture securing device 805 may have anexpanded configuration. In one embodiment, the needle guide 865 may beretracted from the penetration path depositing or releasing the suturesecuring device 805 distally of the vessel wall 870. The projections 875may then move to the expanded configuration wherein the projections 875are substantially non-parallel with the longitudinal axis of the tubularbody 810. In one embodiment, the projections 875 may include one or moreelastic or shape memory materials, such as spring steel, nitinol, and/orother shape memory alloys, and may be heat set to have a memory shape.For example, the projections 875 may be heat set in their expandedconfiguration. As a result, when the suture securing device 805 isdeployed, it may superelastically move to an expanded configuration. Auser may apply a force to the suture securing device 805 to deform theprojections 875 away from their memory shape and move the suturesecuring device 805 into a collapsed configuration, as shown in FIG.10B. Alternatively, the projections 875 may be resiliently biasedtowards the expanded configuration. As a result, when the suturesecuring device 805 is released from an external force such as theneedle guide 865, the projections 875 may move to their expandedconfiguration. In another embodiment, the projections 875 may bepivotally connected to the tubular body 810. In a further embodiment,the projections 875 may be pivotally connected to the proximal end 815of the tubular body 810. When the suture securing device 805 is storedwithin the needle guide 865, the projections 875 may be rotated to thecollapsed configuration. As shown, when the suture securing device 810is deployed from the needle guide 865, the projections 875 can rotate tothe expanded configuration.

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the disclosure is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A method for closing a puncture in a vessel wallof a blood vessel, the method comprising: advancing a guide member intoproximity with a puncture in a vessel wall, the guide member having aproximal end, a distal end, openings near the distal end, and aplurality of needle guides disposed within the guide member; positioninga distal end of an angle adjustment member distal to the openings of theguide member, the angle adjustment member being slidably coupled to theguide member; deploying the needle guides distally and radially awayfrom the guide member through the openings, wherein each needle guidehas a suture attached to a suture securing device; deflecting the needleguides with the angle adjustment member; advancing the deflected needleguides and the suture securing devices through the vessel wall;retracting the needle guides to release the suture securing devicesdistally of the vessel wall; and establishing tension in the sutures tomove the suture securing devices toward each other to thereby close thepuncture.
 2. The method of claim 1, wherein the needle guides aredeployed distally and radially away from the guide member through theopenings and advance through the vessel wall by moving an activationhandle relative to the guide member.
 3. The method of claim 1, furthercomprising advancing an anchor member through the guide member anddistally away from the distal end of the guide member and expanding theanchor member distally of the puncture before deploying the needleguides, wherein the anchor member is expanded to laterally extend beyonda deployment location of at least one of the suture securing devicesadvanced through the vessel wall.
 4. The method of claim 1, furthercomprising positioning a plug against the vessel wall.
 5. The method ofclaim 1, wherein the suture securing device comprises: an elongated bodyhaving a proximal end, a distal end, and an inner cavity; a firstopening in the proximal end of the elongated body, the first openingbeing in communication with the inner cavity; a cutout having aperiphery extending distally from the first opening; a plurality oftissue-engaging elements at least partially surrounding the cutout; andthe suture attached to the elongated body.
 6. The method of claim 5,further comprising moving the elongated body between a first positionwherein the elongated body is substantially parallel with a longitudinalaxis of the suture and a second position wherein the elongated body issubstantially non-parallel with the longitudinal axis of the suture andat least a portion of the suture is received within the cutout such thatthe elongated body can resist proximal movement against a distal surfaceof a vessel wall.
 7. The method of claim 5, further comprising engagingthe plurality of tissue-engaging elements against the vessel wall. 8.The method of claim 1, wherein the suture securing device comprises atapered body.
 9. A method for closing a puncture in a vessel wall of ablood vessel, the method comprising: advancing a guide member intoproximity with a puncture in a vessel wall; positioning a distal end ofan angle adjustment member distal to a distal end of the guide member,the angle adjustment member being slidably coupled to the guide member;deploying a needle guide distally and radially away from the guidemember, the needle guide comprising a securing device; deflecting theneedle guide with the angle adjustment member; advancing the deflectedneedle guides and the securing device through the vessel wall;retracting the needle guide to release the securing device distally ofthe vessel wall; and moving the securing device toward a longitudinalaxis of the guide member to close the puncture.
 10. The method of claim9, further comprising actuating a handle relative to the guide member todeploy the needle guide distally.
 11. The method of claim 9, furthercomprising advancing an anchor member through the guide member to adeployment location within the blood vessel.
 12. The method of claim 11,further comprising expanding the anchor member to laterally extendbeyond a deployment location of the securing device advanced through thevessel wall.
 13. The method of claim 9, further comprising positioning aplug against the vessel wall.
 14. The method of claim 9, wherein atleast a portion of the securing device rotates relative to the needleguide after the securing device is released from the needle guide.
 15. Amethod for closing a puncture in a vessel wall of a blood vessel, themethod comprising: advancing a distal end of a guide member to positionopenings near the distal end into proximity with a puncture in a vesselwall; positioning a distal end of an angle adjustment member distal tothe openings, the angle adjustment member being slidably coupled to theguide member; deploying a plurality of needle guides distally andradially away from the guide member, each needle guide comprising asuture securing device; advancing the deflected needle guides and thesecuring device through the vessel wall; penetrating the vessel wall bydeflecting the needle guides away from a longitudinal axis of the guidemember; deploying each suture securing device from each needle guide ofthe plurality of needle guides; and moving the securing device towardthe longitudinal axis of the guide member to close the puncture.
 16. Themethod of claim 15, further comprising actuating a handle relative tothe guide member to deploy the needle guide distally.
 17. The method ofclaim 15, further comprising advancing an anchor member through theguide member to a deployment location within the blood vessel.
 18. Themethod of claim 17, further comprising expanding the anchor member tolaterally extend beyond a deployment location of the securing deviceadvanced through the vessel wall.
 19. The method of claim 15, furthercomprising positioning a plug against the vessel wall.
 20. The method ofclaim 9, wherein at least a portion of the securing device pivotsrelative to the needle guide after the securing device is released fromthe needle guide.